Status:
ACTIVE_NOT_RECRUITING
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Cutaneous Melanoma
Cutaneous Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
30 minutes of moderate exercise on an arm ergometer, a cycle ergometer, or a treadmill prior to each administration of standard of care checkpoint blockade immunotherapy across all cycles
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Able to read and speak English fluently
- Capable of giving informed consent
- Reported ability to complete 20-30 minutes moderate exercise per positive response to "can you currently walk unaided for six minutes or more?".
- Scheduled for first-time checkpoint blockade immunotherapy with FDA-approved drugs, including avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab in the absence of other therapies (e.g. targeted therapy)
- Melanoma patients (adjuvant setting)
- Melanoma patients (neoadjuvant setting)
- cuSCC patients (neoadjuvant setting)
- Merkel cell carcinoma patients (neoadjuvant setting)
- Participants may also be required to have a full COVID vaccination series; the most up-to-date best practice guidelines for research at Moffitt Cancer Center will dictate the need for such a vaccination series.
Exclusion
- Presence of medical conditions, such as severe cardiovascular disease for which an exercise intervention may not be warranted.
- Presence of major postoperative complications for which an exercise intervention may not be warranted.
Key Trial Info
Start Date :
June 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05358938
Start Date
June 21 2022
End Date
December 1 2025
Last Update
October 31 2025
Active Locations (1)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612